Bradley Merrill Thompson, Member of the Firm in the Health Care and Life Sciences practice, in the firm’s Washington, DC, office, was quoted in Pharma & MedTech Business Intelligence’s The Gray Sheet, in “Industry Proposes Its FDA Guidance Priorities, Reforms,” by Ferdous Al-Faruque. (Read the full version — subscription required.)
Following is an excerpt:
Attorney Bradley Thompson, speaking for the Combination Products Coalition, says he believes even more substantial reforms to FDA's guidance program are needed, perhaps even involving legislative reform that establishes more tools for the agency to get information out on a timely basis. The Combination Product Coalition submitted a Citizen's Petition to FDA in 2012 seeking reforms to make the guidance process more efficient and effect, but has not yet received a response.
Thompson says the current guidance process is failing both in advancing policy making and in conveying the agency's thinking on established policy.
The process "has gotten so complicated and bureaucratic and constipated that it takes years to write a draft guidance; a draft that lacks public input and that frankly never gets substantially revised if it ever gets finalized," said Thompson in an email to "The Gray Sheet." "Further, these guidances ossify-- stagnating because the process of updating them is so burdensome and time-consuming." …
"We can either get new guidance, or we can get draft guidance finalized, but not both without the agency getting more resources," he said. "That's not an acceptable position for the government to take. We need a new approach, since solving the problem with significant new resources does not seem to be in the cards."
